Defining reliable disability outcomes in multiple sclerosis

Brain

Volumn 138, Issue 11, 2015, Pages 3287-3298

  Kalincik, Tomas ^a,b   Cutter, Gary ^c   Spelman, Tim ^a   Jokubaitis, Vilija ^a   Havrdova, Eva ^d   Horakova, Dana ^d   Trojano, Maria ^e   Izquierdo, Guillermo ^f   Girard, Marc ^g   Duquette, Pierre ^g   Prat, Alexandre ^g   Lugaresi, Alessandra ^h   Grand'Maison, Francois ⁱ   Grammond, Pierre ^j   Hupperts, Raymond ^k   Oreja Guevara, Celia ^l   Boz, Cavit ^m   Pucci, Eugenio ⁿ   Bergamaschi, Roberto ^o   Lechner Scott, Jeannette ^p   Alroughani, Raed ^q   Van Pesch, Vincent ^r   Iuliano, Gerardo ^s   Fernandez Bolaños, Ricardo ^t   Ramo, Cristina ^u   Terzi, Murat ^v   Slee, Mark ^w   Spitaleri, Daniele ^x   Verheul, Freek ^y   Cristiano, Edgardo ^z   Sánchez Menoyo, José Luis ^aa   Fiol, Marcela ^ab   Gray, Orla ^ac   Cabrera Gomez, Jose Antonio ^ad   Barnett, Michael ^ae   Butzkueven, Helmut ^a,b,af   more..

^a UNIVERSITY OF MELBOURNE   (Australia)

^b ROYAL MELBOURNE HOSPITAL   (Australia)

^c UNIVERSITY OF ALABAMA   (United States)

^d CHARLES UNIVERSITY   (Czech Republic)

^e UNIVERSITY OF BARI   (Italy)

^f HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^g NOTRE DAME HOSPITAL   (Canada)

^h UNIVERSITY OF CHIETI   (Italy)

ⁱ HÔPITAL CHARLES LEMOYNE   (Canada)

^j Hotel Dieu de Levis Hospital   (Canada)

^k Zuyderland Medical Centre   (Netherlands)

^l HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^m KARADENIZ TECHNICAL UNIVERSITY   (Turkey)

ⁿ Azienda Sanitaria Unica Regionale Marche AV3   (Italy)

^o C MONDINO NATIONAL NEUROLOGICAL INSTITUTE   (Italy)

^p UNIVERSITY OF NEWCASTLE   (Australia)

^q AL AMIRI HOSPITAL   (Kuwait)

^r CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^s Ospedali Riuniti di Salerno   (Italy)

^t HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^u HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^v ONDOKUZ MAYIS UNIVERSITY   (Turkey)

^w FLINDERS UNIVERSITY   (Australia)

^x Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati   (Italy)

^y GROENE HART HOSPITAL   (Netherlands)

^z HOSPITAL ITALIANO DE BUENOS AIRES   (Argentina)

^aa HOSPITAL DE GALDAKAO   (Spain)

^ab FLENI   (Argentina)

^ac CRAIGAVON AREA HOSPITAL   (United Kingdom)

^ad CENTRO INTERNACIONAL DE RESTAURACIÓN NEUROLÓGICA CIREN   (Cuba)

^ae UNIVERSITY OF SYDNEY   (Australia)

^af MONASH UNIVERSITY   (Australia)

more..

Author keywords

clinical trial; disability; outcome measures; prognosis; relapse

Indexed keywords

ADULT; ARTICLE; DISABILITY; DISEASE COURSE; DISEASE DURATION; EXPANDED DISABILITY STATUS SCALE; FEMALE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REMISSION; AGE; COHORT ANALYSIS; LONGITUDINAL STUDY; MIDDLE AGED; PATHOPHYSIOLOGY; REGISTER;

ADULT; AGE FACTORS; COHORT STUDIES; DISABILITY EVALUATION; DISEASE PROGRESSION; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; OUTCOME ASSESSMENT (HEALTH CARE); REGISTRIES;

EID: 84947728518     PISSN: 00068950     EISSN: 14602156     Source Type: Journal    
DOI: 10.1093/brain/awv258     Document Type: Article

References (27)

1. Amato MP, Fratiglioni L, Groppi C, Siracusa G, Amaducci L. Interrater reliability in assessing functional systems and disability on the Kurtzke scale in multiple sclerosis. Arch Neurol 1988; 45: 746-8.
2. Amato MP, Portaccio E. Clinical outcome measures in multiple sclerosis. J Neurol Sci 2007; 259: 118-22.
3. Butzkueven H, Chapman J, Cristiano E, Grand'Maison F, Hoffmann M, Izquierdo G, et al. MSBase: an international, online registry and platform for collaborative outcomes research in multiple sclerosis. Mult Scler 2006; 12: 769-74.
4. Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain 2003; 126 (Pt 4): 770-82.
5. Ebers GC, Heigenhauser L, Daumer M, Lederer C, Noseworthy JH. Disability as an outcome in MS clinical trials. Neurology 2008; 71: 624-31.
6. Filippini G, Del Giovane C, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, et al. Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis. Cochrane Database Syst Rev 2013; 6: CD008933.
7. Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, et al. Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon beta-1b trial in multiple sclerosis. J Neurol Neurosurg Psychiatry 2012; 83: 282-7.
8. Goodkin DE, Cookfair D, Wende K, Bourdette D, Pullicino P, Scherokman B, et al. Inter-and intrarater scoring agreement using grades 1. 0 to 3. 5 of the Kurtzke Expanded Disability Status Scale (EDSS). Multiple Sclerosis Collaborative Research Group. Neurology 1992; 42: 859-63.
9. Healy B, Chitnis T, Engler D. Improving power to detect disease progression in multiple sclerosis through alternative analysis strategies. J Neurol 2011; 258: 1812-9.
10. Hirst CL, Ingram G, Pickersgill TP, Robertson NP. Temporal evolution of remission following multiple sclerosis relapse and predictors of outcome. Mult Scler 2012; 18: 1152-8.
11. Hohol MJ, Orav EJ, Weiner HL. Disease steps in multiple sclerosis: a longitudinal study comparing disease steps and EDSS to evaluate disease progression. Mult Scler 1999; 5: 349-54.
12. Kalincik T, Spelman T, Trojano M, Duquette P, Izquierdo G, Grammond P, et al. Persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis. PLoS One 2013a; 8: e63480.
13. Kalincik T, Vivek V, Jokubaitis V, Lechner-Scott J, Trojano M, Izquierdo G, et al. Sex as a determinant of relapse incidence and progressive course of multiple sclerosis. Brain 2013b; 136 (Pt 12): 3609-17.
14. Leray E, Yaouanq J, Le Page E, Coustans M, Laplaud D, Oger J, et al. Evidence for a two-stage disability progression in multiple sclerosis. Brain 2010; 133 (Pt 7): 1900-13.
15. Liu C, Blumhardt LD. Disability outcome measures in therapeutic trials of relapsing-remitting multiple sclerosis: effects of heterogeneity of disease course in placebo cohorts. J Neurol Neurosurg Psychiatry 2000; 68: 450-7.
16. Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology 2003; 61: 1528-32.
17. Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson, AJ, et al. Defining the clinical course of multiple sclerosis: The 2013 revisions. Neurology 2014; 83: 278-86.
18. Meyer-Moock S, Feng YS, Maeurer M, Dippel FW, Kohlmann T. Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. BMC Neurol 2014; 14: 58.
19. Noseworthy JH, Vandervoort MK, Wong CJ, Ebers GC. Interrater variability with the Expanded Disability Status Scale (EDSS) and Functional Systems (FS) in a multiple sclerosis clinical trial. The Canadian Cooperation MS Study Group. Neurology 1990; 40: 971-5.
20. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 2011; 69: 292-302.
21. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the 'McDonald Criteria'. Ann Neurol 2005; 58: 840-6.
22. Pozzilli C, Prosperini L. Clinical markers of therapeutic response to disease modifying drugs. Neurol Sci 2008; 29 (Suppl 2): S211-3.
23. Ravnborg M, Blinkenberg M, Sellebjerg F, Ballegaard M, Larsen SH, Sorensen PS. Responsiveness of the multiple sclerosis impairment scale in comparison with the expanded disability status scale. Mult Scler 2005; 11: 81-4.
24. Schumacher GA, Beebe G, Kibler RF, Kurland LT, Kurtzke JF, McDowell F, et al. Problems of experimental trials of therapy in multiple sclerosis: report by the panel on the evaluation of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci 1965; 122: 552-68.
25. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2011.
26. Tremlett H, Zhu F, Petkau J, Oger J, Zhao Y. Natural, innate improvements in multiple sclerosis disability. Mult Scler 2012; 18: 1412-21.
27. Weinshenker BG, Issa M, Baskerville J. Meta-analysis of the placebotreated groups in clinical trials of progressive MS. Neurology 1996; 46: 1613-9.